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    Leqembi®

    Drug - Leqembi® (lecanemab-irmb) [Eisai Inc.]

    March 2025

    Therapeutic Area - Alzheimer’s Agents

    Initial approval criteria

    • Patient is ≥ 18 years of age; AND 
    • Patient has a diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild Alzheimer’s dementia as evidenced by all of the following: 
      • Clinical Dementia Rating (CDR)-Global score of 0.5 to 1 
      • Memory Box score ≥ 0.5 
      • Mini‐Mental State Examination (MMSE) score 22 to 30 
      • Objective evidence of cognitive impairment at screening 
      • Positron emission tomography (PET) scan or cerebrospinal fluid (CSF) assessment of amyloid beta (1-42) is positive for amyloid beta plaque; AND 
    • Prescriber attests that other conditions causing similar symptoms have been ruled out (e.g., vascular dementia, dementia with Lewy bodies, frontotemporal dementia, normal pressure hydrocephalus); AND 
    • Prescribed by, or in consultation with, a specialist in neurology or gerontology; AND 
    • Patient does not have risk factors for intracerebral hemorrhage (e.g., prior cerebral hemorrhage > 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, evidence of vasogenic edema, evidence of cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel or white matter disease); AND 
    • Patient has not had a stroke, transient ischemia attack (TIA), or seizure in the last 12 months; AND
    • Patient has not demonstrated clinically significant and unstable psychiatric illness in the last 6 months; AND 
    • Testing for apolipoprotein E Ɛ4 (ApoE Ɛ4) carrier status has been conducted; AND 
    • Prescriber attests to conducting a careful risk-benefit analysis prior to prescribing lecanemab-irmb for patients who are homozygous for ApoE Ɛ4, and for those receiving anti-platelet agents (with the exception of prophylactic aspirin or clopidogrel), anticoagulants (e.g., Factor Xa inhibitors), or anti-thrombins (e.g., heparin); AND 
    • Brain magnetic resonance imaging (MRI) has been obtained prior to treatment initiation; AND 
    • Baseline disease severity has been assessed using an objective measure/tool (e.g., MMSE, Alzheimer's Disease Assessment Scale Cognitive Subscale [ADAS-Cog-13], Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment version [ADCS-ADL-MCI], Clinical Dementia Rating-Sum of Boxes [CDR-SB]).
    • Will NOT be used concurrently with other anti-amyloid immunotherapies; AND
    • Prescriber attests that the patient and/or caregiver understands the risks and benefits of Leqembi therapy AND
    • Prescriber attests that the patient and/or caregiver understands and is committed to receiving scheduled doses and enhanced clinical vigilance during the first 14 weeks of treatment
    • The following documentation must be provided at time of requests:
      • Healthcare facility’s written processes and procedures to support enhanced clinical vigilance during the first 14 weeks of treatment; AND
      • Patient’s educational materials to empower patient and caregiver during the enhanced clinical vigilance period and thereafter including ways to contact prescriber and other relevant clinical staff
    • Initial approval is for 6 months

    Renewal criteria

    • Scoring on an objective measure/tool (e.g., ADAS-Cog 13; ADCSADL-MCI; MMSE; CDR-SB) demonstrates improvement, stability, or slowing in cognitive and/or functional impairment; AND 
    • Patient has not experienced any treatment-restricting adverse effects (e.g., severe hypersensitivity reactions); AND 
    • Patient has undergone MRI prior to the 5th, 7th, and 14th infusions to monitor for ARIA with edema (ARIA-E) or ARIA with hemosiderin deposition (ARIA-H); AND 
    • Leqembi administration will be suspended and not resumed until MRI demonstrates radiographic resolution and stabilization of symptoms in the event of any of the following: 
      • ARIA-E that is asymptomatic or mildly symptomatic with moderate to severe radiographic severity
      • ARIA-E with moderate to severe symptoms and any degree of radiographic severity
      • ARIA-H that is asymptomatic with moderate radiographic severity
      • ARIA-H with moderate to severe symptoms and any degree of radiographic severity
      • ARIA-E or ARIA-H with severe radiographic severity
    • Renewal approval is for 12 months

    Billing for Leqembi

    Leqembi must be billed as a medical claim.

    Quantity limits

    • 10 mg/kg every 14 days 
    • Patient’s most recent weight (in kg) must be submitted at time of request

    Questions

    Provider Call Center (844) 575-7887

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